Modular Spinal Fixation Device

ABSTRACT

A spinal fixation device is provided including a modular head assembly and a bone screw. The modular had assembly includes a housing, an anvil, an insert, and a snap ring. The housing defines a proximal surface and an opposite, distal surface, and the proximal and distal surfaces define a throughbore therethrough. The anvil is configured to be slidably received within a portion of the throughbore. The insert defines a proximal surface and an opposite, distal surface, and the distal surface defines a first counterbore therein that terminates at a first annular surface. The first annular surface defines a second counterbore that terminates at a second annular surface. The snap ring is configured to be disposed within the first counterbore of the insert when in a first configuration, and within the second counterbore of the insert when in a second configuration.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.16/478,944, which is a national phase entry under 35 U.S.C. § 371 ofInternational Application No. PCT/US2018/014179, filed Jan. 18, 2018,which claims priority from U.S. Provisional Patent Application No.62/487,516, filed on Apr. 20, 2017, and U.S. Provisional PatentApplication No. 62/447,515, filed on Jan. 18, 2017, all of which areincorporated herein by reference.

BACKGROUND Technical Field

BRIEF SUMMARY OF THE INVENTION

The present disclosure relates to spinal fixation devices. Moreparticularly, the present disclosure relates to head assemblies for usein modular spinal fixation devices that are connectable to spinal rodsused in spinal constructs.

Description of Related Art

There are many known spinal conditions, e.g., scoliosis, that requirethe imposition and/or maintenance of corrective forces on the spine inorder to return the spine to its normal condition. As a result, numerousdevices (e.g., alignment systems) have been developed for use in spinalfixation. One type of spinal construct may include, for example, one ormore spinal rods that can be placed parallel to the spine with fixationdevices (such as hooks, screws, or plates) interconnected between thespinal rods and selected portions of the spine. The spinal rods can beconnected to each other via cross-connecting members to provide a morerigid support and alignment system. In some cases, the use of thesedevices may be permanently implanted in the patient. In other cases, thedevices may be implanted only as a temporary means of stabilizing orfixing the bones or bone fragments, with subsequent removal when nolonger needed.

When using screws, the surgeon directs the screw into the vertebral bodybefore attaching any additional mechanical hardware, such as rods orbands. In this manner, the surgeon typically attaches the spinalfixation devices to the spine in appropriate anatomical positions andthen attaches the spinal rod to the fixation devices. In conjunction,the surgeon manipulates the spinal column and/or individual vertebra toprovide the desired treatment for the spinal defect. Subsequently, thespinal rod and fixation devices are locked in a desired arrangement.

While the aforementioned spinal fixation devices are suitable for theabove uses, there may exist a need for spinal fixation devices that canreduce the time and labor required by a user to insert a fixationdevice, such as a screw, into a vertebra.

SUMMARY

A spinal fixation device is provided in accordance with the presentdisclosure and includes modular head assembly and a bone screw. Themodular head assembly includes a housing, an anvil, an insert, and asnap ring. The housing defines a proximal surface and an opposite,distal surface, the proximal and distal surfaces defining a throughboretherethrough. The anvil is configured to be slidably received within aportion of the throughbore. The insert defines a proximal surface and anopposite, distal surface. The distal surface defines a first counterboretherein terminating at a first annular surface. The first annularsurface defines a second counterbore therein terminating at a secondannular surface. The snap ring is configured to be disposed within thefirst counterbore of the insert when in a first configuration, andwithin the second counterbore of the insert when in a secondconfiguration. The bone screw defines a head at a proximal portionthereof and a shank extending distally from the head. The bone screw isconfigured to be received within a portion of the snap ring.

In aspects, the distal surface of the housing may define a thirdcounterbore therein terminating at an annular face.

In other aspects, the annular face of the third counterbore may define aslot extending in a proximal direction. The slot extending through aninner surface of the throughbore.

In certain aspects, the anvil may define a proximal surface and anopposite, distal surface, defining an outer surface extendingtherebetween. The outer surface defines a tab extending between theproximal and distal surfaces, the tab configured to be slidably receivedwithin the slot.

In other aspects, an inner surface of the third counterbore may definethreads thereon.

In aspects, the insert may define an outer surface extending between theproximal and distal surfaces, the outer surface defining threads thereonconfigured to threadably engage the threads of the third counterbore.

In certain aspects, the snap ring may define a proximal surface and anopposite, distal surface, the proximal and distal surfaces defining alumen therethrough.

In aspects, the proximal and distal surfaces of the snap ring may definean outer surface extending therebetween, the outer surface defining aslot extending through the proximal and distal surfaces and being inopen communication with the lumen.

In other aspects, the lumen of the snap ring may define a longitudinalaxis extending along a centerline thereof, the lumen defining an innersurface having a concave profile extending along the longitudinal axis.

In certain aspects, the snap ring may be formed from a resilientmaterial.

In other aspects, an intersection of the outer surface of the snap ringand the distal surface of the snap ring may define an undercutconfigured to abut a portion of the second counterbore of the insert.

According to another aspect of the present disclosure, a method ofassembling a spinal fixation device is provided and includes assemblinga modular head assembly, including advancing an anvil within athroughbore defined through a proximal and distal surface of a housing,advancing a snap ring within a first counterbore defined through aproximal surface on an insert, and rotating the insert in a firstdirection to threadably engage a first plurality of threads defined onan outer surface of the insert with a second plurality of threadsdefined on an inner surface of a second counterbore defined through thedistal surface of the housing until the insert is threadably coupled tothe housing. The method further includes placing a bore defined througha distal surface of the insert adjacent a head of a bone screw andadvancing the modular head assembly toward the head of the bone screwsuch that the head of the bone screw is received within the bore of theinsert, and thereafter, within a lumen defined through distal andproximal surfaces of the snap ring to retain the head of the bone screwtherein.

In certain aspects, advancing the anvil within the throughbore of thehousing may include advancing a tab defined on an outer surface of theanvil within a slot defined within an inner surface of the throughboreto inhibit rotation of the anvil relative to the housing.

In other aspects, advancing the head of the bone screw within the lumenof the snap ring may include advancing the head of the bone screw withinthe lumen of the snap ring such that a concave profile defined on aninner surface of the lumen engages the head of the bone screw to retainthe head of the bone screw within the lumen.

In aspects, advancing the head of the bone screw within the lumen of thesnap ring may include the snap ring defining a slot extending through anouter surface thereof and extending through the proximal and distalsurfaces, the slot enabling the snap ring to expand to a second,expanded state, as the head of the bone screw is received within thelumen, and return to a first, unexpanded state once the head of the bonescrew is fully received within the lumen.

In certain aspects, the method may include advancing a spinal rod withina slot defined through an outer surface of the housing and extendingthrough the proximal surface thereof.

In aspects, the method may include rotating a set screw in a firstdirection to threadably engage threads defined on an outer surface ofthe set screw with threads defined on an inner surface of thethroughbore of the housing, wherein rotation of the set screw in thefirst direction causes the set screw to translate in a distal directionwhich causes a corresponding distal translation of the spinal rid, theanvil, and the snap ring.

In other aspects, the method may include further rotating the set screwin the first direction to cause the snap ring to further translate in adistal direction and be received within a second counterbore definedthrough a first annular surface defined by the first counterbore of theinsert, wherein reception of the snap ring within the second counterborecauses the snap ring to compress around the head of the bone screw andlock the orientation of the bone screw relative to the modular headassembly.

In accordance with another aspect of the present disclosure, a method ofassembling a spinal fixation device is provided and includes advancing abone screw within an incision formed in a patient's body, driving thebone screw into a vertebra, the bone screw including a head at aproximal portion thereof and a threaded shank extending distally fromthe head. The method further includes assembling a modular headassembly, including advancing an anvil within a throughbore definedthrough a proximal and distal surface of a housing, advancing a snapring within a first counterbore defined through a proximal surface of aninsert, and rotating the insert in a first direction to threadablyengage a first plurality of threads defined on an outer surface of theinsert with a second plurality of threads defined on an inner surface ofa second counterbore defined through the distal surface of the housinguntil the insert is threadably coupled to the housing. The methodfurther includes placing a bore defined through a distal surface of theinsert adjacent the head of the bone screw and advancing the modularhead assembly toward the head of the bone screw such that the head ofthe bone screw is received within the bore of the insert, andthereafter, within a lumen defined through distal and proximal surfacesof the snap ring to retain the head of the bone screw therein.

BRIEF DESCRIPTION OF THE DRAWINGS

Various embodiments of the present disclosure are described hereinbelowwith references to the drawings, wherein:

FIG. 1A is a front view of a spinal fixation device including a modularhead assembly and a bone screw in accordance with an embodiment of thepresent disclosure;

FIG. 1B is a cross-sectional view of the spinal fixation device of FIG.1A, taken along section-line 1B-1B of FIG. 1A;

FIG. 2 is a perspective view of the spinal fixation device of FIG. 1A,shown with parts separated;

FIG. 3A is a perspective view of a housing of the modular head assemblyof FIG. 1A;

FIG. 3B is a cross-sectional view of the housing of FIG. 3A, taken alongsection-line 3B-3B of FIG. 3A;

FIG. 4 is a perspective view of an anvil of the modular head assembly ofFIG. 1A;

FIG. 5 is a perspective view of a snap-ring of the modular head assemblyof FIG. 1A;

FIG. 6A is a perspective view of an insert of the modular head assemblyof FIG. 1A;

FIG. 6B is a cross-sectional view of the insert of FIG. 6A, taken alongsection-line 6B-6B of FIG. 6A;

FIG. 7A is a front view of the spinal fixation device of FIG. 1A, shownin an assembled state;

FIG. 7B is a cross-sectional view of the spinal fixation device of FIG.1A, taken along section-line 7B-7B of FIG. 7A;

FIG. 8A is a front view of the spinal fixation device of FIG. 1A, shownwith a spinal rod and set screw in accordance with the presentdisclosure;

FIG. 8B is a section view of the spinal fixation device of FIG. 1A andthe spinal rod and set screw of FIG. 8A, taken along section-line 8B-8Bof FIG. 8A;

FIG. 9A is a front view of another embodiment of a spinal fixationdevice including a modular head assembly and bone screw provided inaccordance with the present disclosure;

FIG. 9B is a cross-sectional view of the spinal fixation device of FIG.9A, taken along section-line 9B-9B of FIG. 9A;

FIG. 10 is a perspective view of the spinal fixation device of FIG. 9A,shown with parts separated;

FIG. 11 is a perspective view of a snap ring of the modular headassembly of FIG. 9A;

FIG. 12 is a perspective view of an anvil of the modular head assemblyof FIG. 9A;

FIG. 13 is a front view of the anvil of FIG. 12;

FIG. 14A is a front view of the spinal fixation device of FIG. 9A, shownin an assembled state;

FIG. 14B is a cross-sectional view of the spinal fixation device of FIG.9A, taken along section-line 14B-14B of FIG. 14A;

FIG. 15A is a side view of the spinal fixation device of FIG. 9A, shownwith a spinal rod and set screw provided in accordance with the presentdisclosure;

FIG. 15B is a cross-sectional view of the spinal fixation device of FIG.9A and the spinal rod and set screw of FIG. 15A, taken alongsection-line 15B-15B of FIG. 15A;

FIG. 16A is a front view of yet another embodiment of a spinal fixationdevice including a modular head assembly and a bone screw provided inaccordance with the present disclosure;

FIG. 16B is a cross-sectional view of the spinal fixation device of FIG.16A, taken along section-line 16B-16B of FIG. 16A;

FIG. 17 is a perspective view of the spinal fixation device of FIG. 16A,shown with parts separated;

FIG. 18A is a side view of an insertion tool; and

FIG. 18B is a detail view of the area of detail indicated in FIG. 18A.

DETAILED DESCRIPTION

Embodiments of the present disclosure are now described in detail withreference to the drawings in which like reference numerals designateidentical or corresponding elements in each of the several views. Asused herein, the term “clinician” refers to a doctor, a nurse or anyother care provider and may include support personnel. Throughout thisdescription, the term “proximal” will refer to the portion of the deviceor component thereof that is closer to the clinician and the term“distal” will refer to the portion of the device or component thereofthat is farther from the clinician. Additionally, in the drawings and inthe description that follows, terms such as front, rear, upper, lower,top, bottom, and similar directional terms are used simply forconvenience of description and are not intended to limit the disclosure.In the following description, well-known functions or constructions arenot described in detail to avoid obscuring the present disclosure inunnecessary detail.

Referring now to the drawings, FIGS. 1A, 1B, and 2 illustrate anembodiment of a spinal fixation device provided in accordance with thepresent disclosure and generally identified as reference numeral 10. Thespinal fixation device 10 includes a modular head assembly 12 and a bonescrew 14, although it is contemplated that the spinal fixation devicemay only include the modular head assembly 12, depending upon the needsof the procedure being performed. As can be appreciated, it iscontemplated that the modular head assembly 12 may be utilized with aspinal hook or other similar spinal fixation devices.

The modular head assembly 12 includes a housing 16, an anvil 18, a snapring 20, and an insert 22. With additional reference to FIGS. 3A and 3B,the housing 16 includes a body portion 16 a extending between a proximalsurface 16 b and an opposite, distal surface 16 c defining alongitudinal axis A-A therethrough. Although generally illustrated ashaving a cylindrical profile, it is contemplated that the body portion16 a may include any suitable profile capable of being used duringspinal surgery. The proximal surface 16 b of the housing 16 defines athrough-hole 24 therethrough that extends through the distal surface 16c of the housing 16. An inner surface 24 a of a proximal portion of thethrough-hole 24 defines a plurality of threads 24 b configured tothreadably engage a set screw 40 (FIG. 8B), as will be described infurther detail hereinbelow. A distal portion of the inner surface 24 aof the through-hole 24 defines a pair of slots 24 c disposed injuxtaposed relation to one another and extending along the longitudinalaxis A-A. Although illustrated as defining a pair of slots 24 c, it iscontemplated that the inner surface 24 a of the through-hole 24 maydefine only one slot 24 c. Each slot 24 c is configured to slidablyengage a corresponding feature of the anvil 18 to enable translation ofthe anvil 18 within the through-hole 24, but inhibit rotation of theanvil 18 within the through-hole 24. In this manner, the pair of slots24 c ensures that a U-shaped slot 28 of the housing 16 remains alignedwith a concave relief 18 g (FIG. 4) defined in the anvil 18, as will bedescribed in further detail hereinbelow.

The distal surface 16 c of the body portion 16 a defines a counterbore26 extending towards the proximal surface 16 b and terminating at anannular face 26 a located at a middle portion of the body portion 16 a,although it is contemplated that the counterbore 26 may extend anysuitable distance from the lower portion 16 c. An inner surface 26 b ofthe counterbore 26 defines a plurality of threads 26 c configured tothreadably engage the insert 22, as will be described in further detailhereinbelow.

An outer surface 16 d of the body portion 16 a of the housing 16 definesa U-shaped slot 28 therethrough and extending through the proximalsurface 16 b thereof. As can be appreciated, the U-shaped slot 28 isconfigured to receive a spinal rod 34 (FIG. 8A), as will be described infurther detail hereinbelow. As illustrated in FIG. 2, the outer surface16 d of the body portion 16 a defines a pair of reliefs 30 therein whichare aligned with the U-shaped slot 28 (e.g., oriented transverse to thelongitudinal axis A-A). The pair of reliefs 30 is configured to engage asuitable tool (not shown) to enable a clinician to grasp and manipulatethe modular head assembly 12 during the surgical procedure. It iscontemplated that the housing 16 may be formed from any biocompatiblematerial suitable for use in surgical procedures, such as metallicmaterials (e.g., titanium (e.g., commercially pure titanium), titaniumalloys, (e.g., Ti-6Al-4V), stainless steels, cobalt chrome alloys, etc.)or non-metallic materials (e.g., ceramics, polyetheretherketone (PEEK),etc.).

With additional reference to FIG. 4, the anvil 18 defines a body portion18 a extending between a proximal surface 18 b and an opposite, distalsurface 18 c defining a longitudinal axis B-B therethrough. The bodyportion 18 a includes a profile that is complimentary to the profile ofthe through-hole 24 of the housing 16 such that the anvil 18 is capableof being slidably received therein. An outer surface 18 d of the bodyportion 18 a defines a pair of tabs 18 e thereon extending along thelongitudinal axis B-B. In embodiments, it is contemplated that the outersurface 18 d may form only a single tab 18 e thereon. Each tab 18 e isoriented 180 degrees apart relative to the other tab 18 e such that eachtab 18 e of the pair of tabs 18 e is received within a correspondingslot 24 c of the pair of slots 24 c of the housing 16 to permit theanvil 18 to translate within the through-hole 24 along axis A-A, butinhibit rotation of the anvil 18 relative thereto. The proximal anddistal surfaces 18 b, 18 c define a bore 18 f therethrough. The proximalsurface 18 b defines a relief 18 g therein having a concave profile(e.g., extending toward the distal surface 18 c) and configured toreceive a portion of the spinal rod 34 (FIG. 8A) therein. As can beappreciated, the anvil 18 may be formed from any material suitable foruse in surgical procedures, such as those described hereinabove, and maybe formed from the same or a different material than the housing 16.

The snap ring 20 is illustrated in FIG. 5 and is configured to beslidably received within a portion of the insert 22 (FIG. 1B), as willbe described in further detail hereinbelow. The snap ring 20 includes agenerally cylindrical body 20 a extending between an upper surface 20 band an opposite, lower surface 20 c defining a longitudinal axis C-Ctherethrough. Although generally illustrated as having a cylindricalprofile, it is contemplated that the body 20 a may include any suitableprofile, and may conform to the profile of the portion of the insert 22in which the snap ring 20 is configured to be received. The upper andlower surfaces 20 b, 20 c define a lumen 20 d therethrough which definesa curvate inner surface 20 e thereon. The curvate inner surface 20 edefines a generally concave profile extending along the longitudinalaxis C-C and generally corresponds to the profile of a head 14 a of thebone screw 14 (FIG. 2). An outer surface 20 f of the body 20 a defines aslot 20 g therethrough extending through the inner surface 20 e of thelumen 20 d and through the upper and lower surfaces 20 b, 20 c such thatthe slot 20 g is in open communication with the lumen 20 d. In thismanner, the slot 20 g interrupts a perimeter of the snap ring 20 suchthat the snap ring 20 forms a generally C-shaped profile which enablesthe body 20 a to expand and compress (e.g., the outer diameter of thebody 20 a increases or decreases) due to an external or internal forcebeing applied thereto. The proximal surface 20 b defines a channel 20 gtherein extending transverse to the longitudinal axis C-C and disposedopposite to the slot 20 d. The intersection of the distal surface 20 band the inner surface 20 f of the body 20 a defines a bevel 20 i thatextends towards the lumen 20 d. The intersection of the distal surface20 c and the outer surface 20 f of the body 20 a defines an undercut 20j that extends towards the lumen 20 d. It is contemplated that the snapring 20 may be formed from any material suitable for use in surgicalprocedures such as those described hereinabove, and may be formed fromthe same or a different material than the housing 16 and the anvil 18.In one non-limiting embodiment, the snap ring 20 is formed from aresilient material that enables the snap ring to expand and compresswithout being permanently deformed.

Turning now to FIGS. 6A and 6B, an embodiment of the insert 22 isillustrated. The insert 22 includes a body 22 a defining a generallycylindrical profile extending between a proximal surface 22 b and anopposite, distal surface 22 c. An outer surface of the body 22 a definesa plurality of threads 22 d configured to threadably engage theplurality of threads 26 c of the counterbore 26 of the housing 16 suchthat the insert 22 may be threadably coupled to the housing 16. Theproximal surface 22 b defines a first counterbore 22 e thereinterminating at a first annular surface or annular shoulder 22 f disposedapproximately halfway between the proximal and distal surfaces 22 b, 22c of the body 22 a. In embodiments, it is contemplated that the firstannular surface 22 f may be disposed at any suitable location dependingupon the needs of the procedure being performed. The first annularsurface 22 f defines a second counterbore 22 g therein terminating at asecond annular surface or annular shoulder 22 h disposed adjacent thedistal surface 22 c of the body 22 a. The second counterbore 22 g isconcentric with the first counterbore 22 e and includes a diameter thatis less than the first counterbore 22 e. In this manner, the firstcounterbore 22 e is configured to slidably receive the snap ring 20therein whereas the second counterbore 22 g is configured to compressthe snap ring 20 as the snap ring 20 is received therein. In thismanner, the second counterbore 22 g compresses around a head of the bonescrew 14 to secure the bone screw 14 in position relative to the housing16, as will be described in further detail hereinbelow.

The second annular surface 22 h of the second counterbore 22 g defines abore 22 i therethrough and extending through the distal surface 22 c ofthe body 22 a. Although generally illustrated as being disposedconcentric with the second counterbore 22 g, it is contemplated that thebore 22 i may be defined at any suitable location on the second annularsurface 22 h. The bore 22 i defines a diameter capable of permitting thehead of the bone screw 14 to pass therethrough, as will be described infurther detail below. It is contemplated that the insert 22 may beformed from any material suitable for use in surgical procedures such asthose described hereinabove, and may be formed from the same or adifferent material than the housing 16, anvil 18, and/or snap ring 20.In embodiments, the insert 22 is formed from a material that is as hardor harder than the material forming the snap ring 20, such that neitherthe snap ring 20 nor the insert 22 is damaged as the snap ring 22transitions from the first counterbore 22 e to the second counterbore 22g of the insert 22.

Returning to FIGS. 1A, 1B, and 2, an embodiment of a bone screw 14capable of being used with the modular head assembly 12 is illustrated.Although generally illustrated as being a poly-axial pedicle screw, itis contemplated that the bone screw 14 may be any suitable bone screwcapable of being used during spinal surgery (e.g. mono-axial oruni-axial). The bone screw 14 includes a head 14 a at a proximal endthereof and a shank 14 b extending distally therefrom. The shank 14 bincludes a distal tip portion 14 c, an elongated body portion 14 d, anda proximal end 14 e that is coupled to the head 14 a (e.g.,monolithically formed therewith). The distal tip portion 14 c isgenerally conically-shaped to facilitate insertion of the bone screw 14into bone, and in embodiments, may be self-tapping or self-starting. Theelongated body portion 14 d of the shank 14 b includes a substantiallyuniform outer diameter and includes a continuous helical thread 14 f ofsubstantially uniform pitch formed thereon to allow for threadedinsertion and retention of the bone screw 14 within the bone. It iscontemplated that the thread 14 f disposed about the elongated bodyportion 14 d of the shank 14 b may be single threaded, double threaded,etc., depending upon the needs of the procedure being performed. Inembodiments, it is contemplated that the shank 14 b may be cannulated topermit passage of a guide wire (not shown) or other instrumentationtherethrough.

The head 14 a of the bone screw 14 defines a generally spherical shapeand defines a tool engaging recess 14 g at a proximal portion thereofthat is configured to engage the engagement region 310 of the driver 300(FIGS. 18A, 18B). As can be appreciated, the tool engaging recess 14 gmay define any suitable shape capable of transmitting the rotationalmotion of the tool to the head 14 a of the bone screw, and in onenon-limiting embodiment, may define a hexalobe configuration. It iscontemplated that the bone screw 14 may be formed from any materialsuitable for use in surgical procedures such as those describedhereinabove, and may be formed from the same or a different materialthan the housing 16, the anvil 18, the snap ring 20, and/or the insert22. In embodiments, the head 14 a of the bone screw 14 may be formedfrom a different material than the shank 14 b of the bone screw.

For a detailed description of the construction of a bone screw capableof being utilized with the modular head assembly 10 described herein,reference may be made to U.S. Pat. No. 9,393,048, titled “PolyaxialBonescrew Assembly,” the entire contents of which is hereby incorporatedby reference herein.

With reference to FIGS. 2, 7A, and 7B, a method of assembling the spinalfixation device 10 is illustrated. Initially, the anvil 18 is positionedbelow the counterbore 26 of the housing 16 with the pair of tabs 18 e ofthe anvil aligned with the pair of slots 24 c of the housing 16. Theanvil 18 is urged in a proximal direction into the counterbore 26 suchthat the pair of tabs 18 e is received within the pair of slots 24 c.

FIGS. 7A and 7B illustrate the spinal fixation system 10 in an assembledstate. Initially, the modular head assembly 12 of the spinal fixationsystem 10 is assembled by first aligning the pair of tabs 18 e of theanvil with the corresponding pair of slots 24 c of the through-hole 24of the housing 16. Once the pair of tabs 18 e is in alignment with thepair of slots 24 c, the anvil is advanced in a proximal direction withinthe through-hole 24 until an upper portion of the pair of tabs 18 eabuts a proximal-most portion of the pair of slots 24 c. Next, the snapring 20 is placed adjacent the counterbore 26 of the housing 16 andadvanced in a proximal direction such that the snap ring 20 is slidablyreceived therein. With the snap ring 20 received within the counterbore26, the insert 22 is initially placed adjacent the counterbore 26 of thehousing 16. The insert 22 is then rotated in a first direction such thatthe plurality of threads 22 d of the insert threadably engages thecorresponding plurality of threads 26 c of the counterbore 26 of thehousing 16. The insert 22 is further rotated until the insert 22 isfully received within the counterbore 26. In this position, the anvil 18is in a proximal most position and the snap ring 20 is disposed withinthe first counterbore 22 e of the insert 22 such that the snap ring 20is in a first, uncompressed state.

With the modular head assembly 12 in an assembled state, the bone screw14 is driven into bone using the driver 300 (FIGS. 18A, 18B) engagedwith the tool engaging recess 14 g of the head 14 a of the bone screw14. With the bone screw 14 secured at a desired location, the modularhead assembly 12 is placed adjacent the head 14 a of the bone screw 14.The modular head assembly 12 is then advanced in a distal direction suchthat the head 14 a of the bone screw 14 is received within the bore 22 iof the insert 22, and thereafter, within the lumen 20 d of the snap ring20. As the head 14 a of the bone screw 14 advances within the bore 22 iof the snap ring 20, the head 14 a causes the snap ring 20 to expand(e.g., the diameter enlarges) to accept the head 14 a therein. As can beappreciated, the concave inner surface 20 e of the lumen 20 d conformsto the spheroid profile of the head 14 a such that the diameter of thesnap ring 20 reduces from an expanded state during insertion of the head14 a therein to a compressed state where the inner diameter of the lumen20 d conforms to the diameter of the head 14 a and provides acompressive force thereon (e.g., an intermediate position that isbetween the expanded state and the clamped state described hereinbelow).

With additional reference to FIGS. 8A and 8B, it is contemplated thatthe axial orientation of the bone screw 14 relative to the modular headassembly 10 may be locked when a suitable spinal rod 34 is securedwithin the housing 16 using a suitable set screw 40. In this manner, thespinal rod 34 is inserted within the U-shaped slot 28 of the housing 16and is received within the relief 18 g and abuts the anvil 18. At thispoint, using a suitable tool or driver 300 (FIGS. 18A and 18B) insertedwithin a tool engaging recess 40 a defined within the set screw 40, theset screw 40 is inserted into the through-hole 24 of the housing. Theset screw 40 defines a plurality of threads 42 thereon to threadablyengage the plurality of threads 24 b of the through-hole 24. In thismanner, using the driver 300, the set screw 40 is rotated in a firstdirection to cause the set screw 40 to translate in a distal directionand urge the spinal rod 34 in a corresponding distal direction.Continued rotation of the set screw 40 in the first direction causes theset screw 40 to further urge the spinal rod 34 in a distal directionwithin the through-hole 24 and in turn, causes the spinal rod 34 to urgethe anvil 18 in a distal direction. The distal translation of the anvil18 urges the snap ring 20, along with the bone screw 14 capturedtherewithin, to translate into the second counterbore 22 g of the insert22. The smaller diameter of the second counterbore 22 g causes the snapring 20 to compress around the head 14 a of the bone screw 14, therebyclamping the head 14 a of the bone screw 14 and fixing the rotationaland angular position of the bone screw 14 with respect the housing 16.

If the angle at which the modular head assembly 10 has been lockedrelative to the bone screw 14 is undesirable, or if the modular headassembly 10 must be removed for any reason, using the driver 300, theset screw 40 is rotated in a second, opposite direction to translate theset screw 40 in a proximal direction. Continued rotation of the setscrew 40 in the second direction enables the set screw 40 to be removedfrom the through-hole 24 of the housing 16. As can be appreciated, itmay not be necessary to completely remove the set screw 40 from thehousing 16 to enable repositioning of the modular head assembly 10relative to the bone screw 14. At this point, the housing 16 of themodular head assembly 10 may be urged in a distal direction. As thehousing 16 translates relative to the bone screw 14, the head 14 a ofthe bone screw 14 urges the snap ring 20 in a proximal direction, whichin turn, causes the snap ring 20 to translate from the secondcounterbore 22 g of the insert 22 to the first counterbore 22 e of theinsert 22. Translation from the second counterbore 22 g to the firstcounterbore 22 e enables the snap ring 20 to transition from a second,compressed state where the modular head assembly 10 is inhibited frommovement relative to the bone screw 14, to the first, uncompressed statewhere the modular head assembly 10 is permitted to move relative to thebone screw 14. At this point, the modular head assembly 10 may be placedin the desired position relative to the bone screw 14 and modular headassembly 10 may be locked relative to the bone screw using the proceduredescribed hereinabove.

Turning to FIGS. 9A, 9B, and 10, another embodiment of a spinal fixationdevice is illustrated and generally identified by reference numeral 110.The spinal fixation device 110 is substantially similar to the spinalfixation device 10, and therefore, only the differences therebetweenwill be described hereinbelow in the interest of brevity.

With reference to FIGS. 10 and 12, the pair of tabs 118 e of the anvil118 extend distal of the lower surface 118 c to define a correspondingpair of extensions 118 h. In embodiments, only a single extension 118 hmay be defined regardless of if there is only a single tab 118 e or apair of tabs 118 e defined on the anvil 118. An inner surface 118 i ofeach extension of the pair of extensions 118 h defines a barb orprotrusion 118 j extending toward one another (e.g., in an interiordirection) and are configured to grasp a corresponding feature definedin the head 114 a of the bone screw 114, as will be described in furtherdetail hereinbelow.

With additional reference to FIG. 11, the inner surface 120 e of thesnap ring 120 defines a pair of opposed channels 120 g therein extendingthrough each of the upper and lower surfaces 120 b, 120 c. The pair ofopposed channels 120 g is configured to slidably receive the pair ofextensions 118 h of the anvil 118 and inhibit rotation of the snap ring120 relative to the anvil 118, and in turn, the housing 116.

Returning to FIGS. 9A, 9B, and 10, another embodiment of a bone screw isprovided and generally identified by reference numeral 114. The bonescrew 114 is substantially similar to the bone screw 14 and thereforeonly the differences therebetween will be described hereinbelow in theinterest of brevity. An outer surface 114 d of the head 114 of bonescrew 114 defines a pair of opposed reliefs 114 e. The pair of reliefs114 e is disposed approximately at the equator (e.g., the widest portionof the head 114) and define a generally triangular profile such that theapex of the pair of reliefs is disposed adjacent the distal end of thehead 114 a. Each relief of the pair of reliefs 114 e is configured toslidably receive a respective extension of the pair of extensions 118 hof the anvil 118. The depth and width of the pair of reliefs 114 d mayvary depending upon how much angular movement of the bone screw 114relative to the housing 116 is desired. In this manner, a pair ofreliefs 114 d having a smaller width will allow a corresponding smallamount of angular movement of the bone screw 114 relative to the housing116 of the modular head assembly 112. Similarly, a pair of reliefs 114 ehaving a larger width will allow a corresponding larger amount ofangular movement of the bone screw 114 relative to the housing 116.Further, the pair of reliefs 114 e inhibits rotation of the bone screw114 about the longitudinal axis C-C since after assembly, the pair ofextensions 118 h compress against the pair of reliefs 114 e to constrainmovement of the bone screw 114 to a single plane.

Assembly of the spinal fixation device 110 is substantially similar tothe assembly of the spinal fixation device 10, and therefore only thedifferences therebetween will be described in detail hereinbelow. Withadditional reference to FIGS. 14A and 14B, during insertion of the snapring 120 within the housing 116, the pair of opposed channels 120 g ofthe snap ring is aligned with the pair of extensions 118 h of the anvil118 such that as the snap ring 120 is urged in a proximal direction, thepair of extensions 118 h of the anvil 118 are received within the pairof opposed channels 120 g. Similarly, the pair of reliefs 114 e of thebone screw 114 is initially aligned with the pair of extensions 118 h ofthe anvil 118. Thereafter, the bone screw 114 is urged in a proximaldirection such that each extension of the pair of extensions 118 h isreceived within a corresponding relief of the pair of reliefs 114 e.

With reference to FIGS. 14A-15B, the process to lock the axialorientation of the bone screw 114 relative to the modular head assembly112 is substantially similar to that of locking the bone screw 14relative to the modular head assembly 12. Therefore, only thedifferences therebetween will be described herein in the interest ofbrevity. As the set screw 40 is rotated in the first direction to urgethe spinal rod 34 in a distal direction, the anvil 118, along with thesnap ring 120 is urged also urged in a distal direction and into thesecond counterbore 122 g of the insert 122. The smaller diameter of thesecond counterbore 122 g causes the snap ring 120 to compress around thehead 114 a of the bone screw 114, as well as the pair of extensions 118h of the anvil 118. In this manner, in addition to the compressive forceapplied to the head 114 a of the bone screw 114, the snap ring 120compresses the pair of extensions 118 h against the pair of reliefs 114d to apply additional compressive force to the head 114 a of the bonescrew 114 to ensure the axial orientation of the bone screw 114 relativeto the modular head assembly 112 is locked. The process to readjust theaxial orientation of the bone screw 114 relative to the modular headassembly 112 is substantially similar to the process to readjust theaxial orientation of the bone screw 14 relative to the modular headassembly 12 and therefore, will not be described herein in detail.

Turning now to FIGS. 16A, 16B, and 17, yet another embodiment of aspinal fixation device is illustrated and generally identified byreference numeral 210. The spinal fixation device 210 is substantiallysimilar to the spinal fixation device 10, and therefore, only thedifferences therebetween will be described in detail hereinbelow in theinterest of brevity.

The bone screw 214 is a mono-axial bone screw and includes a head 214 aat a proximal end thereof and a threaded shank 214 b extending distallytherefrom. The head 214 a includes a proximal end and a distal end andmay define a generally spheroid configuration. The proximal end of thehead 214 a defines a tool engaging recess 214 c that is configured toengage the engagement region 310 of the driver 300. As can beappreciated, the tool engaging recess may define any suitable shapecapable of transmitting the rotational motion of the tool to the 214 aof the bone screw 214, and in one non-limiting embodiment may define ahexalobe shape. The distal end of the head 214 a defines a collar 214 dhaving a proximal facing annular surface 214 e that is configured toabut a portion of the snap ring 220 when the head 214 a is capturedtherein, as will be described in further detail hereinbelow.

Assembly of the spinal fixation device 210 is substantially similar tothat of the spinal fixation device 10 and therefore, only thedifferences therebetween will be described in detail hereinbelow in theinterest of brevity. After the bone screw 214 has been secured into boneat the desired location, the modular head assembly 212 is advanced in adistal direction such that head 214 a of the bone screw 214 is receivedwithin the bore 222 i of the insert 222, and thereafter, within thelumen 220 d of the snap ring 220. As the head 214 a of the bone screw214 advances within the lumen 220 d of the snap ring 220 and is capturedtherein, the proximal facing annular surface 214 e of the collar 214 dof the bone screw 214 abuts a proximal surface of the snap ring 220 andinhibits radial movement of the bone screw 214 relative to the modularhead assembly 212, but permitting axial rotation thereof relative to themodular head assembly 212 (e.g., about longitudinal axis C-C). In thismanner, the bone screw 214 is constrained to movement in a single axis,and therefore is considered a mono-axial bone screw.

With reference to FIGS. 18A and 18B, a driver suitable for use with thespinal fixation device 10 is provided and generally identified byreference numeral 300. The driver includes an elongate shaft 302 havinga proximal portion 304 and an opposed distal portion 306. The proximalportion 304 of the elongate shaft 302 defines a handle 308 that isconfigured to enable a clinician to selectively rotate the driver 300(e.g., by gripping the handle 308 and applying rotational forcethereto). The distal portion 306 of the driver 300 tapers to a drivingbut or a reduced diameter engagement region 310. The engagement region310 includes protrusions 312 and recesses 314 that are complementary tothe tool engaging recess 14 g of the bone screw and the tool engagingrecess 40 a of the set screw 40. Once the engagement region 310 isinserted into the tool engaging recesses 14 g or 40 a, rotation of thedriving tool 300 results in rotation of the bone screw 14 or the setscrew 40. Thus, the driving tool 300 is capable of rotating the bonescrew 14 and the set screw 40 for insertion or removal of the bone screwinto bone and insertion or removal of the set screw 40 into the housing16.

While several embodiments of the disclosure have been shown in thedrawings, it is not intended that the disclosure be limited thereto, asit is intended that the disclosure be as broad in scope as the art willallow and that the specification be read likewise. Therefore, the abovedescription should not be construed as limiting, but merely asexemplifications of particular embodiments. Those skilled in the artwill envision other modifications within the scope and spirit of theclaims appended hereto.

1. A spinal fixation device, comprising: a modular head assembly,comprising: a housing defining a proximal surface and an opposite,distal surface, the proximal and distal surfaces defining a throughboretherethrough; an anvil configured to be slidably received within aportion of the throughbore; an insert defining a proximal surface and anopposite, distal surface, the distal surface defining a firstcounterbore therein terminating at a first annular surface, the firstannular surface defining a second counterbore therein terminating at asecond annular surface; a snap ring configured to be disposed within thefirst counterbore of the insert when in a first configuration, andwithin the second counterbore of the insert when in a secondconfiguration; and a bone screw defining a head at a proximal portionthereof and a shank extending distally from the head, the bone screwconfigured to be received within a portion of the snap ring.